Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer

Ovarian Cancer Clinical Trial

Official title:

THE ROLE OF FLOSEAL IN THE PREVENTION OF LYMPHOCELE AND LYMPHATIC ASCITES AFTER LYMPH NODE DISSECTION FOR GYNECOLOGIC CANCER: A RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679483
• Other study ID #: FloSeal-LND
• Status: Completed
• Phase: N/A
• First received: September 3, 2012
• Last updated: May 27, 2017
• Start date: September 2012
• Est. completion date: November 2015

Study information

• Verified date: May 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use FloSeal during lymph node dissection

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube

• FIGO stage Cervical cancer: FIOG stage IA2-IIA2 Uterine cancer: FIGO stage I-III Ovarian and fallopian tubal cancer: FIGO stage I-IIIB

• Patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection

• Patients with adequate bone marrow, renal and hepatic function:

WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal

• American Society of Anesthesiology Physical Status 0-1

• Performance status of ECOG 0-2

• Patient must be suitable candidates for surgery

• Patients who have signed an approved Informed Consent

Exclusion Criteria:

• Patients with a history of pelvic or abdominal radiotherapy;

• Patients who are pregnant

• Patients with contraindications to surgery;

• Patients who are unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);

• Patient's compliance and geographic proximity that do not allow adequate follow-up.

• Patients who undergo only lymph node sampling

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Fallopian Tubal Cancer
• Gynecologic Cancer
• Lymphocele
• Ovarian Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• FloSeal application
At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.

Locations

Country	Name	City	State
Korea, Republic of	Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Baxter Healthcare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of lymphocele an lymphatic ascites		within 1 year after surgery
Secondary	Time interval from surgery to removal of closed drain system		with 2 weeks after surgery
Secondary	Postoperative drain amount		with 2 weeks after surgery
Secondary	Postoperative hospital stay		within 2 weeks after surgery
Secondary	Postoperative bleeding incidence		within 2 weeks after surgery
Secondary	Postoperative complication incidence		within 1 month after surgery
Secondary	Quality of life		within 1 year after surgery
Secondary	2-year disease free survival and overall survival		2 years after surgery